Originally published as JCO Early Release 10.1200/JCO.2008.18.4408 on March 16 2009

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Randomized Phase II Study of Gefitinib Compared With Placebo in Chemotherapy-Naive Patients With Advanced Non–Small-Cell Lung Cancer and Poor Performance Status

From the Ottawa Hospital Cancer Center, Ottawa; AstraZeneca, Toronto; Durham Regional Cancer Center, Oshawa, Ontario, Canada; New Cross Hospital, Wolverhampton; Birmingham Heartlands Hospital, Birmingham; AstraZeneca, Macclesfield, United Kingdom; Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, the Netherlands; and the University of Colorado Cancer Center, Denver, CO.

Corresponding author: Glenwood Goss, MB, BCh, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, 501 Smyth Rd, Ottawa, Ontario K1H 8L6, Canada; e-mail: ggoss{at}ottawahospital.on.ca.

Purpose To compare gefitinib with placebo in chemotherapy naïve patients with advanced non–small-cell lung cancer (NSCLC) and poor performance status.

Patients and Methods NSCLC patients (chemotherapy naïve, WHO performance status 2 or 3; unfit for chemotherapy; stage IIIB/IV) were randomly assigned to gefitinib (250 mg/d) plus best supportive care (BSC; n = 100) or placebo plus BSC (n = 101). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), quality of life (QOL), pulmonary symptom improvement (PSI), and safety. Correlation of gefitinib efficacy with EGFR gene copy number (fluorescent in situ hybridization [FISH]) was explored.

Results Hazard ratios (HRs; gefitinib:placebo) were 0.82 (95% CI, 0.60 to 1.12; P = .217) for PFS and 0.84 (95% CI, 0.62 to 1.15; P = .272) for OS. As expected for this patient population, OS for both arms was poor, at about 3 months. ORRs were 6.0% (gefitinib) and 1.0% (placebo). QOL and PSI rates were 21.1% and 28.3% (gefitinib) and 20.0% and 28.3% (placebo), respectively. In EGFR FISH-positive patients (n = 32), HRs were 0.29 (95% CI, 0.11 to 0.73) for PFS and 0.44 (95% CI, 0.17 to 1.12) for OS. No unexpected adverse events occurred.

Conclusion There was no statistically significant difference in PFS, OS, and ORRs after treatment with gefitinib or placebo, in the overall population; improvements in QOL and symptoms were similar in both groups. Tolerability profile of gefitinib was consistent with previous studies. PFS was statistically significantly improved for gefitinib-treated patients with EGFR FISH-positive tumors.

Supported by AstraZeneca.

Presented in part at the 12th World Conference on Lung Cancer, Seoul, Korea, September 2-6, 2007; the National Cancer Research Institute Annual Meeting, Birmingham, United Kingdom, September 30 to October 3, 2007; and at the 1st European Lung Cancer Conference, Geneva, Switzerland, April 23-26, 2008.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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